NCT06492525

A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers

A Phase 1, Open-label, 2-period, Fixed Sequence, Cross-over Study To Investigate The Effect Of Multiple Doses Of Rifampicin Or Itraconazole On The Pharmacokinetics Of Single Dose Ensartinib In Healthy Volunteers.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ensartinib	225 mg oral dose on day 1 in period 1 and on day 18 in period 2
DRUG	Rifampicin	600 mg QD from day 9 to day 22 in period 2
DRUG	Itraconazole	200 mg QD from day 9 to day 19 in period 2
DRUG	Ensartinib	100 mg oral dose on day 1 in period 1 and on day 12 in period 2

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2024-07-09
• Last updated: 2024-07-09

Locations

1 site across 1 country: China